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Clinipace Brings Strategic Level of Global Regulatory and Development Experience to Novel Therapy Trial
Clinipace Worldwide, a global digital clinical research organization (dCRO), announced today that Nexstim, a leader in navigated stimulation of the brain, has selected the company to manage the US-based clinical trial for its Navigated Brain Therapy (NBT) System.
Based in Helsinki, Finland, Nexstim develops and markets Navigated Brain Stimulation (NBS) Systems for use in diagnostics and pre-surgical mapping. In 2012, Nexstim launched a novel NBT device for the treatment of brain injury and disease using repetitive transcranial magnetic stimulation (rTMS) guided by a patient’s own MRI scan. While initial results show great promise in helping stroke patients regain lost motor control, the NBT System also enables personalized non-drug treatment for people suffering from major depressive disorder (clinical depression). The NBT System and therapeutic use for stroke and depression are not cleared indications in the US.
The NBT System meets the requirements of the European Medical Devices Directive (MDD) and has been CE marked accordingly. Nexstim’s non-invasive NBT System is not yet approved by the Food and Drug Administration for therapy in commercial use in the United States and is available to select physicians for investigational use only.
“Building a strategic partnership with a CRO with proven global expertise managing regulatory submissions andapprovals is critical to the success of our US-based trial,” noted Rainer Harjunpää, Vice President, Quality Assurance and Regulatory Affairs. “Clinipace brings the right balance of regulatory and strategic development experience, working with global regulatory agencies to ensure we are compliant based on regional standards of care, standards of diagnosis, and other factors such as global marketing approval processes.”
“Clearly, new treatments such as Nexstim’s NBT System are urgently needed; however, the development of novel therapies has been traditionally hindered by challenges in conducting clinical research,” commented Jeff Williams, CEO, Clinipace Worldwide. “Our TEMPOTM eClinical platform helps investigators make faster, better informed decisions. This technology-amplified approach to clinical research helps clients like Nexstim speed and facilitates start-up of study sites, patient accrual, clinical monitoring, site management, all the way through study close-out.”